FDA Regulation 21-CFR-300

FDA Regulation 21-CFR-300.50 Fixed-combination prescription drugs for humans

[Revised as of April 1, 2009]

[Code of Federal Regulations]

[Title 21, Volume 5]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR300.50]

[Page 5]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN

SERVICES (CONTINUED)

PART 300_GENERAL--Table of Contents

Subpart B_Combination Drugs

Sec. 300.50 Fixed-combination prescription drugs for humans.

The Food and Drug Administration's policy in administering the new-

drug, antibiotic, and other regulatory provisions of the Federal Food,

Drug, and Cosmetic Act regarding fixed combination dosage form

prescription drugs for humans is as follows:

(a) Two or more drugs may be combined in a single dosage form when

each component makes a contribution to the claimed effects and the

dosage of each component (amount, frequency, duration) is such that the

combination is safe and effective for a significant patient population

requiring such concurrent therapy as defined in the labeling for the

drug. Special cases of this general rule are where a component is added:

(1) To enhance the safety or effectiveness of the principal active

component; and

(2) To minimize the potential for abuse of the principal active

component.

(b) If a combination drug presently the subject of an approved new-

drug application has not been recognized as effective by the

Commissioner of Food and Drugs based on his evaluation of the

appropriate National Academy of Sciences-National Research Council panel

report, or if substantial evidence of effectiveness has not otherwise

been presented for it, then formulation, labeling, or dosage changes may

be proposed and any resulting formulation may meet the appropriate

criteria listed in paragraph (a) of this section.

determined to be effective for labeled indications by the Food and Drug

Administration, based on evaluation of the NAS-NRC report on the

combination, is considered to be in compliance with the requirements of

this section.

[40 FR 13496, Mar. 27, 1975, as amended at 64 FR 401, Jan. 5, 1999]